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Design for Manufacturing was a hot topic of conversation at this month’s OMTEC conference. During the opening day R&D symposium, Ken Trimmer, Senior Director, Packaging and Engineering Standards at Stryker, moderated a panel discussion about applying DFM principles early during development projects to accelerate product timelines and minimize costly redesigns.
He was joined by Julien Prevost, Director of R&D at Medtronic, and Andie Pequegnat, Ph.D., Director of Lightspeed at Resonetics, for an engaging conversation about ways to begin development projects with the end in mind to ensure seamless transitions from prototype to production.
Rapid Prototyping to Scale
Dr. Pequegnat said the use of computer-aided design (CAD) is the foundation for downstream execution of development projects, including programming manufacturing equipment, defining the manufacturing strategy and translating the design intent into a device that can be produced at scale. In many cases, it also supports inspection planning and tooling development.
According to Prevost, the CAD model is also a critical communication tool that allows engineers to clearly convey design intent to suppliers and manufacturing partners. “Without that shared reference, we lose the ability to effectively negotiate manufacturability tradeoffs or align on how to achieve the required yield and quality targets,” he said.
It’s that collaboration that enables scalability. The goal is not just to build a prototype that works, but to ensure the design can be reliably manufactured as a commercial product.
Prevost believes rapid prototyping, especially with the rise of 3D printing, has become an incredibly powerful tool, allowing engineering teams to refine new concepts and better understand how a product might be manufactured.
“It also enables us to bring physical prototypes to suppliers early in the process, which is extremely valuable,” he said. “That shared, tangible reference helps initiate discussions around manufacturability and allows suppliers to provide feedback on how they would approach production.”
Strong partnerships with suppliers and manufacturing teams ensure that prototypes can be efficiently produced at scale.
Rapid prototyping within the Lightspeed group at Resonetics centers on precision machining and turning iterations around as quickly as possible. Dr. Pequegnat’s group receives RFQs in which speed is the primary driver and sometimes there’s no formal drawing, just a CAD model.
In those cases, his team needs to be creative by using off-the-shelf materials and available stock sizes. The resulting prototype may not match the exact material properties or design intent they’d want for the final product, and it may not be the most cost-effective or scalable solution, but the goal is speed and learning.
“The challenge is that what we learn in that rapid prototype phase doesn’t always translate directly into a manufacturable, high-volume product,” Dr. Pequegnat said. “That’s why I think there needs to be an additional step, almost a pilot phase, between prototype and full production.”
During that phase, an engineer’s initial concept can be reviewed collaboratively with manufacturing suppliers to confirm that the design intent will be preserved before committing to production.
Getting on the Same Page
Challenges arise between OEMs and manufacturing suppliers in distinguishing between critical dimensions and default tolerances on a drawing. Suppliers must work with OEM engineers to clearly define critical design dimensions and ensure they are fully inspected and controlled in production.
The issue is that this approach often doesn’t account for the cost implications or the burden it places on suppliers. Over-defining critical characteristics can significantly increase manufacturing complexity, inspection requirements and overall program cost.
Instead, Dr. Pequegnat said, design teams need to focus on the clinical outcome the device is intended to achieve, such as the performance of the implant and its interface with the instruments being used. From there, it becomes a matter of balancing design intent with manufacturability.
“I like seeing critical dimensions clearly called out on drawings,” Dr. Pequegnat said. “In some cases, they’re not defined as well as they should be, so that level of clarity is helpful.”
That comes down to OEMs having strategic partnerships with their suppliers so they can have conversations about which design elements are critical for a device’s function. It’s about being thoughtful in how design requirements are defined and verified in order to balance risk, manufacturability and inspection that ensures quality and consistency.
“From my perspective, a key part of the engineer’s role is to truly understand the functional range of the design,” Trimmer said. “That means asking: What is the tightest a dimension needs to be? What is the loosest it can be and still function? And what is the realistic capability range of the manufacturing process?”
Design intent must align with manufacturing reality and define what matters for a device’s function and performance while avoiding unnecessary precision that adds cost and complexity without adding value.
“It’s important, especially from the design perspective, to clearly and repeatedly communicate intent to suppliers,” Prevost said. “Our systems are becoming increasingly complex and that ultimately impacts the final design of the product.”
In some cases, tight tolerances are required and must be clearly communicated to suppliers to prevent them from interpreting the drawing in isolation. “The goal is to ensure the product performs as intended for the patient,” Prevost said. “Achieving that requires strong communication with suppliers so they can align their processes with the actual functional requirements rather than just the nominal drawing.”
Medtronic relies on its suppliers to actively engage in the design process and challenge assumptions to help ensure products are manufacturable and scalable. Prevost said that level of collaboration is what ultimately enables successful commercialization.
Planning for Growth
The panelists highlighted the importance of designing with scalability, not just feasibility, in mind at the prototype stage. “First and foremost,” Dr. Pequegnat said, “it’s about understanding the timeline so we can properly align expectations and prepare for what’s required to meet it.”
In some cases, the question becomes whether suppliers can take a phased approach to a project to meet immediate needs while also planning for additional validation work later on the project or potentially adjusting the process over time.
“It’s also important to think ahead about what the regulatory team will accept in terms of future changes or process refinements,” Dr. Pequegnat said. “Ideally, the core process flow, such as contact materials or key manufacturing steps, remains consistent, so that any later adjustments can be more easily justified through revalidation or supporting data.”
Early alignment across engineering, manufacturing, suppliers and regulatory functions helps ensure that decisions made upfront don’t create unnecessary friction or risk later in the product lifecycle.
Suppliers that work with OEMs to prototype parts collaboratively can run capability studies, apply statistical analysis and understand how the design will behave at volume. That early insight identifies risks before they become embedded in a finalized design.
“What’s also critical is capturing lessons learned from every prototype build,” Dr. Pequegnat said. “Each iteration provides valuable data, but that information is often lost when the focus is purely on speed. Taking the time to collect and analyze that data early makes it much easier to design a process that is scalable and cost effective.”
Trimmer described the push and pull between production and development teams. Production suppliers are typically focused on throughput and efficiency. They want to get parts onto machines, finalize programs and establish work-holding so they can run stable, repeatable processes. On the other hand, development engineers often work on much shorter timelines. They need parts in hand within a couple of weeks for lab work, testing or to intentionally push designs to failure and learn from them.
“The real challenge is finding the right balance,” Trimmer said. “You need to know when a design has matured enough that it makes sense to transition from rapid prototyping to engaging production suppliers for the next iteration of parts.”
So, the question becomes: Where is the sweet spot? At what point do you ask production suppliers to start building parts for testing, knowing that the design may still evolve, and invest time and cost upfront in exchange for better scalability later?
“Balancing speed of iteration with the realities of scalable manufacturing remains an ongoing challenge in product development,” Trimmer said.
OEMs must work harder than ever to improve communication levels and provide suppliers with more information, including cost targets, expected volumes and the timing of specific development milestones or commercial launch.
“By sharing that level of detail, our suppliers and partners can better map out their capacity and plan over the next six to twelve months,” Prevost said. “It allows them to align their resources, tooling strategy and scheduling with our development trajectory.”
That level of transparent communication effectively manages risk and accelerates development programs by ensuring OEMs and suppliers are aligned on intent and execution.
“It comes down to moving away from a traditional supplier relationship and toward a true partnership model,” Prevost said. “The goal should be to reduce friction and move beyond transactional interactions. Instead, we need to operate as partners who are aligned on shared objectives and long-term success. That shift is what allows us to accelerate development and ultimately deliver better outcomes for patients more efficiently.”
